We are a boutique CDMO in Massachusetts that provides full CMC services for biologics, applying technical and regulatory sciences expertise to bring products from preclinical phase to global approvals. Established in 2009, we are a highly flexible organization with a creative team passionate about product development that becomes an extension of client’s team.

We are seeking a driven, highly organized Senior Scientist that is technically strong in biologics product development to develop CMC project plan in collaboration with internal team and client, and to ensure delivering project objectives on target.

STC Biologics is a boutique CDMO within the hub of biotechnology in MA that provides integrated biopharmaceutical CMC services. Our high flexibility combined with technical and regulatory sciences expertise provides unique advantage to clients for bringing their products from preclinical phase to global approvals.

We are seeking a talented mass spectrometrist. With us, you have the opportunity to learn a diverse range of CMC activities and regulatory sciences while contributing to advancing complex therapeutic products through clinical development.

Key Responsibilities

Develop and execute detailed analytical plans in an agile manner with minimal re-work.

In close collaboration with Quality, design and execute protocols for phase-appropriate validation of analytical methods, troubleshoot assay performance issues, contribute to addressing Investigations and Deviations

In close collaboration with Process development and Quality, develop in-process and raw materials tests; support in-process testing and contribute to batch records

Support writing proposals with swift response to client. Then drive efficient execution of diverse projects that necessitates working with manager to maneuver resources in a matrixed and fast paced environment

Demonstrated experience with the development of a broad range of analytical methodologies for characterization of biotherapeutics. Experience with biophysical methods, and analysis of complex mixtures and nanoparticles highly desirable

Knowledge of GMP requirements and ICH guidelines desirable

Competencies

Drive and flexibility to meet objectives efficiently in a fast pace environment

STC Biologics, Inc. offers a variety of internship opportunities. Interns at STC go through a rigorous program in developing skills in all areas of drug development from discovery to process and analytical development. Thus far we have trained students from various universities from Massachusetts including Boston University, University of Massachusetts & Babson College. We seek eager young scientists who are smart, driven and able to multi-task. At STC, we believe in mentoring young scientists to become proficient professionals in the industry and acquiring the necessary personal and professional skills for a successful career.

If you are interested in applying or would like to seek more information about our career opportunities please send your request to: